MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,ADMINISTRAITON,INTRAVASCULAR

Model Number	11088483
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: non-bd extension set; broviac central line; syringe 10ml; syringe 3ml.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.Additional patient information: infant; race: w.
Event or Problem Description
It was reported that the infants mother noticed that the patients blankets were wet during a 6.9ml flush infusing from a 10ml syringe after a hydrocortisone 3ml dose was administered via the patient's broviac central line located in the patient's left femoral artery.
Event or Problem Description
It was reported that the infants mother noticed that the patients blankets were wet during a 6.9ml flush infusing from a 10ml syringe after a hydrocortisone 3ml dose was administered via the patient's broviac central line located in the patient's left femoral artery.
Additional Manufacturer Narrative
The customer¿s report of a leak during a 6.9ml flush infusing from a 10ml syringe was not confirmed because the sets reprimed and infused completely during functional testing.The sets were visually inspected for cracks, misassembles or damages to the components.Clear liquid was observed within the tubing.No abnormalities were observed.Functional testing was performed by repriming the sets using the as-received 10 ml syringe with blue dye water.One 18 gauge cannula was attached.The syringe plunger was depressed but no leaks occurred.The cannula was replaced by a stopcock in the closed position to create backpressure.The syringe plunger was depressed again but no leaks were observed.The sets were loaded into a lab syringe module.An infusion rate was not provided, therefore the primary infusion was programmed at a rate of 6.9 ml/h and vtbi at 6.9 ml.The primary infusion completed with no alarms or any issues of leaks.The sets were loaded into a lab syringe module.An infusion rate was not provided, therefore the primary infusion was programmed at a rate of 6.9 ml/h and vtbi at 6.9 ml.The primary infusion completed with no alarms or any issues the sets were pressure tested while submerged underwater.Air pressure was incrementally increased from 5 psi to 30 psi.No anomalies or leaks were observed at connections or throughout the sets.The root cause was not identified.

• Brand Name: EXTENSION SET
• Common Device Name: SET,ADMINISTRAITON,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8786595
• Report Number: 9616066-2019-01908
• Device Sequence Number: 16734251
• Product Code: FPA
• UDI-Device Identifier: 10885403234668
• UDI-Public: 10885403234668
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11088483
• Device Catalogue Number: 11088483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,PRI TUBING,8100, TD: (B)(6) 2019; 8015,PRI TUBING,8100, TD: (B)(6) 2019
• Patient Age: 10 MO